MANAGEMENT OF PRIMARY AND SECONDARY STERILITY (TILL DELIVERY WITH ALO ES COMPOUND AND LEPTADEN IN THE MOFUSSlL AND RURAL AREAS IN INDIA
(A Retrospective Study or 5000 cases,)
BAKULA P. SHMI, B.Sc., M.8,ll.S., L.M., D.G.O., (Dublin), D.R.C.O.G.,
M..R.C.O.C., (lond), Shah Surgical & Maternity Hospital, Amravati – 444 601, Maharashtra
Introduction.- Management of infertility is a human problem and a challenge to medical science all over the world. It is a problem even in metropolitan centres where sophisticated equipment and highly qualified personnel are available for advice and the patients belong to the better socio-economic groups. Even with tremendous scientific ·advances, management of infertility remains unsatisfactory. Even surgical measures, whenever necessary, have a limited role in the management of infertility. Medical treatment with Clomiphene and Gonadotrophin has got limited usefulness and has got its own hazards. Against this background, clinical management of infertility in mofussil and rural areas where there are no facilities for investigations and patients are of a poor socioeconomic status, can well be imagined:
Review of 5000 cases (1969-77).-Incidence of infertility is considered to be about 10% to 15% even when all obvious factors like anovulation, tubal blockage, polycystic ovaries, cervical incompetence etc. are excluded. There are a number of couples who are apparently normal and fail to conceive. These couples have a low “Fertility Index”.
During a period of 9 years – (1969-71) about 5OOO ·cases · of irregular, scanty menstruation and associated infertility were treated with Aloes Compound (Alarsin) in our private Maternity Hospital from the very first visit, irrespective of the cause or duration of infertility, to improve menstrual rhythm and fertility index. Husbands were put on tablet Fortege to correct probable semen defects and for better sex performance, except those who bac1 azoospermia. Those women who conceived were put on Leptaden throughout pregnancy.
Aloes Compound, Fortege and Leptaden are herbal drugs and are without the hazards of hormonal treatment. A n umber of clini cal research studies on these drugs, whicfi su pport the clin ical use of thes druszs in the management of infertility , na mely to help li) conception, (ii) undisturbed pregnancy and ( iii ) full term live baby that survives and thrives, are pu blishcd.
Most of these cases have primary & secondary sterility asociated with irregular and or scary menstruation . Our general observation arc that in the majority of cases alces compound led to successful conception. On reviewing these cases we found that the majority of the cases had full term live births.
Aloes compound :-It consists of aloes indica, myrrh, manjishta, hurmal, loha bhasma, jivanti kamboji. Aloes, myrrh and iron were used since centuries for menstrual disorders in India as well as in Western Countries. In fact, aloes et myrrh and aloes et ferri were Pharma drugs before the advent of hormone therapy.
Manjishta and hurmal correct menstrual disorders of psychic origin as they act on nervous system. They have neurogenic stimulating action on uterine muscles. ·
Jivanti and Kamboji :-These have neuro-glandular system activati ng properties, regularise uterine and ovarian functions· and nor malic and help n.idation of zygote and environmental factors for conception.
Fortege :-Fortege relieves fatigue (Sexual, nervous, muscular), which helps better sex performance, encourages spermatogenesis, and corrects oljgospcrmia and poor motihty where present and thus improves proper insemination.
Lepraden :-(Jivanti, Kamboji ):-Leptaden has the properties of garbhashanya sodhan, garbha athapan and sothagna and neuroglandular activating properties. Leptaden regularises uterine and ovarian functions, helps nidation of zygote and normalises environmental factors for conception. This ensures sustenance of conception leading to a full term live baby that is healthy, survives and thrives.
Facilities at mofussil places.- In a mofussil place like Amravati with limited facilities at our disposal, elaborate investigations of in fert ile couples were not possible. The only investigation that was eaily done in every case was semen analysis. Many of the female partners had undergone dilatation and currettege but except in a few women the histological studies were not possible because of the expenses involved. Similarly hysterosalpingogram is even more costly and could be done only in a few cases.
Analysis of 300 cases :-On reviewing the results of the cases treated with aloes compound du ring 1969-1977 in our private hospital, we found that results were surprisingly encouraging and hence it was thought worth while to have an analysis of some of these cases.
A retrospective study of 300 cases :-Material and methods. This study consists of cases from our hospital. These cases were picked up at random to avoid any bias. However, those cases where more data was avai1able and normal examinations and tests were done were included in the study. The semen analysis of the husbands was one of the factors for the selection of the cases. Cases of azoospermia an· not included in this study.
Five cases of sterin-Leventhal syndrome are included in this st udy separately.
Age Groups: – Majority of infertility woman (62% ) belong to the age group of 26-30 years. 78% of cases were in the age group of 21-30 Years ( Table I )
Age of Menarch : – Of the total 50% of cases had their first Menstrual period at the age of 14 years. On the whole 86% of them had their menarche between 14-16 years of age ( Table II)
Duration of marriage : – Primary sterility: 29.6 % of the infertile couples (Primary) were married for 5 years or less. It was slightly less (24.9%) for those who were married for 5- 10 years. But there was a gain rise in the number of infertile couples who were married for 11-15 years, (31.8%) Infertility was the in those who were married for 16-20 years, forming 13.7% of the total (Table III )
Secondary Sterility: No of children:-The were 36 women with secondary sterility. 28 of them had a regular r menstrual cycle. 10 women had children aged 3-5 year, another 10 had children aged 6-10 years and 8 had children aged 11-15 years. 8 women had secondary sterility after M. T. P. 2-4 years back. (Table IV).
Uterus, cervix and ovaries:- The uterus was of small size in. 30 cases. It was retroverted in 24 cases and retroverted and mobile in 12 cases. Cervix was adherent in 6 cases. The pinpoint cervix is seen in.42 cases.
Thirty cases of the retroverted uterus were corrected by Hod Pessarv and 6 cases underwent ventrisuspension. D and C did in all the cases of the pinpoint cervix. In 6 cases of the adherent cervix, a blunt operation was done and separated. In 5 cases of Ste. Leventhal Syndrome, laparotomy was done and wedge resection was made.
Histopathological examination :-Endometrial examination (PJ menstrual) could be done in 42 cases out of 300 cases. Of these, showed secretory phase and 18 showed proliferative phase and it was undetermined in 6 cases. (Table V)
Semen examination:-The semen was examined in all the bands of the infertile couples. There were 6 husbands where the mere count was less than 30 million/cc. These were deemed to be cases of oligospermia. No established case of azoospermia was included in the study.
Tubal patency test: -All these 300 infertile women had the tubes patent. The patency was determined by insufflation of hysterosalpingography. No case of tubal obstruction was included in the study
Menstrual pattern:- 22.7% of cases had a normal menstrual pattern, 77.3% had irregular scanty menstruation. This may be predominant cause of female infertility. (Table Vl).
Dosage scheme of Aloes compound:- In all cases of infertility, where menstruation was regrular, aloes compound was given 2 tabs. three times a day for 15-25 days after menstruation {1st day). This was continued for every cycle till conception took place or to a maximum period of eight months.
In all cases where menstruation was irregular, scanty or irregular scanty, aloes compound was given continuously, , 1 tab. Threee times a day, except during the menstrual period. After. the menstrual period becomes normal, they were given 2 tablets three a day during 15-45 days after menstruation (1st Day).
In cases of Stein Leventhal Syndrome. After the wedge resection, they were put on aloes compound 2 tablets, 3 times a day for 15-25 days after menstruation (1st day). This was to help early correction of menstrual irregularly and help conceptions.
In all those cases, where a mother came subsequently for advice, seeking a second child.. she was immediately put on aloes compound, 2 tabs. three times for 15-25 -days after menstruation (1st day). No further treatment was given when a cycle was missed.
Fortege: Husbands with oligospermia and low motility of sperms were put on Fortege 2 tabs. t.d.s. for three months or more. Others were given Fortege 2 tabs. b.d for three months or more to tone up sexual, muscular and nervous systems.
Leptaden:-Women who conceived after aloes compound treatment were put on Leptaden 2 tabs. b.d. throughout pregnancy.
Results.– Note:- In tabulating the results of these randomized group of 300 cases, the ultimate goal of the management of infertility, namely live births, is mainly taken into consideration. Other details are inc1uded and evaluated because of the importance in the management of infertility. We would like to mentio11 that these cases were spread out for over a period of 8 to 9 years and hence, the results are to be considered as suggestive as they are not put to statistical evaluation.
Menstrual pattern:- After aloes compound therapy, the conception rate amon 68 women of normal menstrual pattern was 67 6%. (46 cases). Among 232 women who were treated for irregular, scanty menstruation, the conception rate was 87•5% (203 cases). faking both the groups together (300), after aloes compound therapy, the conception rate was 83 0% (249 cases). (Table Vll).
Conception rate in month of aloes compound therapy :- On the whole 29 women among 300 conceived. Among the 249 cases, the conception took place in 3-5 months in 67•J %, in 6-8 mont11.5 in 26•1%, in 9-11 months in 3•2% and in 12-15 months in 3.2%. (Table VIII).
Conception rate as per histopathological finding: -Endometrial trial biopsy could be done only in 36 women. Out of 18 women who showed secretary phase the conception rate was 100 0%. Among those 18 women who showed Proliferative phase the conception rate was 33.3% (6 cases). (Table No. IX).
Conceptions rate amongst those opted for Stein-Leventhal syndrome: Among 5 women who were operated and later put on aloes compound therapy, 3 cases conceived. (60%) [ Table X]
The final outcome of conception : the outcome of any pregnancy is of utmost importance as a live birth with a healthy and thriving child is natural aspiration if all couples, Out of 249 conceptions after aloes compound therapy, full term or preterm live births formed 88.0 % (219 Cases), there was one still birth, & there were 21 abortions (8 4%) at 12 week& of gestation. Post-natal infant mortality (0-4 weeks) was 8 children (3•2%). (Table XI).
Stein – Leventhal syndrome: – All the five cases under this group underwent surgery and bilateral wedge resection of ovaries were performed. The resected specimens were sent for histopathology and the diagnosis was confirmed. Out of five cases, three conceived. One of them once and two sisters twice each, one by Caesarean section on both occasions and the other sister by Caesarian section followed by normal delivery, the second time. The other 2 patients came for checkup after the operation and reported as having regular periods with a good flow. Unfortunately, they failed to report further as they were from remotpartspreventing followup.
Cases of conception after abortion or infant mortality:–There were 21 cases where the infertile women conceived, but there was an abort ion at about 12 weeks. All these were given aloes compound again and all of them conceived in 3–5 months of therapy. There were 8 cases where the infant died within one month of delivery due to specticamia, respiratory infection etc. When they did not conceive in two years, they were put on aloes compound again. and all conceived in 3-6 months and delivered a normal child. There was l still birth and the mother did not conceive for two years. She was put on al compound and she conceived and delivered normal Child.
Second conception .- Atleast 40 women who were treated for primary sterility with aloes compound and delivered a child, had a second conception after two years and delivered a normal child. 1hesc included those cases that delivered other than in my hospital but were later reported to me personally or by their neighbours or relatives
Toxic or side effects: -No toxic effects were observed with the use of aloes compound. 6 cases reported occasional diarrhoea and abdominal discomfort but they could continue the therapy.
Discussion -It is worth noting that aloes compound gave comparatively better conception results in cases of irregular, scanty menstruation than in those cases where menstruation was normal. This suggests that aloes compound improves fertility index.
Those cases where their husbands had azoospermia are excluded in this study as mentioned before.
Once conception was confirmed, aloes compound was stopped and leptaden was started and was continued throughout pregnancy. Leptaden was given in a dose of 2 tabs. b.d. for sustenance of pregnancy and for the birth of a live and healthy child. Recent studies on leptaden, have shown its clinical usefulness in threatened abortion, habitual abortion and premature births.
Our clinical experince extending over 9 years shows that aloes compound, leptaden and fortege have definite value in the management of primary and secondary sterility.
No side or adverse e ffects were observed with alces compound, lcptaden or fortege. On the whole the results were highly satisfactory.
Acbowledgement.-Our thanks arc due to M/s ALARSIN Pharmaceuticals Bombay-400 023, for,their co-operation . ‘
References:
Mrs Balsara Roshan R (1966) – The Indian Practitioner, 19:1-123-5, Jan
Miss Bhatia Geeta (1971)- Current Med. Pract.15 :4 715-17 April
Deshpande P J (1962)- The Antiseptic, 59:12, Dec
Mrs. Gupta Kusum (1972) – Aloes Compound (A Herbal Drug) In Functional Sterility – XVI All India Obst. And Gynec Congress New Delhi, 10-12 March
Jhaveri, C L Mrs.Ila S Moody, Mrs Munim, J M amd Miss Das, PG (1972)- Clinical evaluation in Infertility associated with irregular menstrual cycles treated with an indigenous preparation- XVI All India Obst and Gynec Cingress, New Delhi 10-12 March.